Italian Supreme Court, Third Section, Judgment No. 8224/2025

Factual background

A leading international biopharmaceutical company was sued to ascertain its civil liability pursuant to Articles 2043 and 2050 of the Italian Civil Code (ICC). A patient was given a flu vaccine that allegedly caused a severe form of encephalomyelitis. The patient subsequently died.

The action was based on the assumption that the drug was placed on the market without adequate prior testing to exclude the risk of serious adverse effects, like those that occurred. The defendant claimed that no liability profile existed, asserting that the vaccine wasn’t dangerous, since it had passed all required safety checks and regulatory approvals, and pointing to the previous medical conditions of the injured party.

First and second instance proceedings

The court of first instance partially upheld the plaintiff's claims. It asserted the company's product liability under the Consumer Code because the vaccine was found to be defective due to the lack of adequately conducted clinical studies on the subjects most affected.

Both parties appealed the decision. But the Court of Appeal rejected the appeals, upholding the first instance ruling in its entirety. The Court of Appeal reaffirmed “the existence of a product defect, consisting in the lack of up-to-date and necessary clinical studies on the effects of the vaccine in the elderly individuals with co-morbidities such as diabetes, heart disease and discopathies” and therefore the existence of a causal link between damage suffered and the company's conduct.

The Supreme Court decision

The pharmaceutical company appealed to the Supreme Court, alleging infringement of Articles 117, 118 and 120 of the Consumer Code. It complained that the Court of Appeal had applied a plurality of criteria of judgement, creating an impermissible overlap.

The territorial court initially attributed the case under the product liability rules, which are based on specific assumptions, ie the consumer must prove the damage, the defect in the product and the causal link. Subsequently, its decision was based on the assumptions of Article 2050 ICC (which regulates tort liability in dangerous activities), generating a mixture between the two regulations. The company further objected to how the burden of proof was handled, arguing that defectiveness and causation were presumed.

The court noted that, in cases of harm resulting from administering a vaccine, the legal system allows recourse to different liability regimes, as confirmed by Article 127 of the Consumer Code. It’s possible to invoke product liability regime governed by Articles 114–127 of Legislative Decree No. 206/2005, extra-contractual liability pursuant to Article 2043 ICC, and “objective” liability for dangerous activities under Article 2050 ICC. Nevertheless, the court emphasized the impossibility of combining these regimes, each of which is based on its own rationale and distinct criteria of attribution of liability. The overlap of the relevant rules leads to an error of legal classification (subsumption).

Although the Court of Appeal claimed to apply the regime of extra-contractual liability under Article 2043 ICC, it introduced a burden of proof not provided for by that provision; the realising proof of the damaging party.

The ruling effectively ends up altering the nature of product liability rules, bringing it unduly closer to the model set forth under Article 2050 ICC, which entails a duty of ongoing scientific monitoring even after the product has been placed on the market. While the legal system permits the alternative use of different liability regimes, it's essential to emphasize the inadmissibility of combining them. Each regime has to be applied independently and consistently with its own underlying principles and attribution criteria.

The Supreme Court concluded by overturning the second instance ruling and clarifying that, although the injured party is entitled to choose from the various liability regimes provided by the legal system, once the choice has been made, the judge has to apply exclusively the rules specific to the chosen regime, without overlapping criteria derived from other models of liability.